Steerable catheter having disposable module and sterilizable handle and method of connecting same

ABSTRACT

A catheter and methods are provided for inserting at least portions thereof into a vessel, cavity, or tissue of a human body to thereby provide manipulation of a distal portion of the catheter when positioned within a vessel, cavity, or tissue. The catheter preferably has a module which includes an elongate tube having at least one lumen extending from a distal end to a proximal end of the tube, a module interface connected to the proximal end of the tube, and a deflector connected to the tube for deflecting the distal portion of the elongate tube. A handle detachably connects to the module and is configured to be readily held in the hand of a user. The handle has a body which includes a wall positioned in and extending transversely across distal portions of the body. The wall has an outer surface thereof defining an exterior portion of the body and a first cavity formed within the body. Preferably, the body detachably and coextensively connects to the module interface through the outer surface of the wall. A controller is connected to the body and detachably connects to the deflector of the module for responsively controlling the deflector to thereby manipulate distal portions of the elongate tube. The controller and the deflector connect to define a unitary catheter manipulator extending from the first cavity, through the wall, and to the tube for manipulating a distal portion of the catheter when positioned within a vessel, cavity, or tissue.

This application is a Divisional of Ser. No. 08/598,804 filed on Feb. 9,1996 now U.S. Pat. No. 5,860,953.

RELATED APPLICATIONS

This application is related to and a continuation-in-part of four designapplications: Ser. No. 29/046,932, filed Nov. 21, 1995 for SteerableCatheter now abandoned; Ser. No. 29/048,898 filed Jan. 16, 1996 forHandle For Steerable Catheter now U.S. Pat. No. D405,881; Ser. No.29/049,058, filed Jan. 16, 1996 for Steerable Catheter now abandoned;and Ser. No. 29/048,899, filed Jan. 16, 1996 for Handle Interface ForSteerable Catheter now U.S. Pat. No. D398,986.

FIELD OF INVENTION

This invention relates generally to medical catheters and morespecifically to steerable catheters for inserting into vessels,cavities, or tissue of the human body.

BACKGROUND OF THE INVENTION

Various commercially available endoscopes and steerable catheters existfor introducing a variety of surgical tools, fluids, and other materialssuch as radiographic contrast materials, angioplasty balloons, fiberoptic scopes, laser lights, and cutting instruments into the vessels,cavities, or tissue of a human body. Also, various techniques andsystems have been developed for guiding or steering the catheters orendoscopes in body vessels or cavities for use with these tools, fluids,and other materials. Therapeutic or diagnostic treatments may be made byinserting surgical instruments or fluid through a working channel orlumen of a catheter.

Catheters conventionally include a conduit or flexible tube forinserting into a cavity, duct, or vessel of the human body to allowfluids to pass therethrough or to allow instruments to be insertedthrough the tube. Catheters also have been developed with steeringmechanisms to guide or manipulate the catheter such as seen in U.S. Pat.No. 5,199,950 by Schmitt et al. titled "Medical Instrument." Endoscopesare generally tools used to view within a portion of the anatomy throughan open end of a tube. Flexible endoscopes have been constructed for usewithin "tube-like" portions or cavities of the anatomy (e.g., arteries,ureters, common bile duct). Endoscopes have been designed for the userto look directly through an objective lens or in conjunction with videocameras attached remotely to the scope for viewing a portion of thehuman body. Rod lens systems also have been used with some endoscopes toview images. In other endoscopes, the image is gathered at the distalend by a lens and transferred to a proximal objective lens using fiberoptic bundles.

During use in medical procedures, endoscopes and steerable catheters areexposed to various viruses, bacteria, and harmful disease carryingmedia. These viruses and bacteria can be trapped in the endoscope orsteerable catheter, particularly in lumens and transferred to subsequentpatients or users. During use of these medical devices, microbes havealso been trapped inside patient materials that remain in the endoscopesand become coated with lubricants and various organic materials in theendoscope. If not effectively eliminated, these materials can and havebeen transferred to other patients or medical personnel throughsubsequent use of the endoscope or steerable catheter. In the humanbody, enzymes and digestive processes work to release these internallytrapped microbes from the lubricant coatings. These harmful microbes caninfect the subsequent patients or medical personnel with dangerous ordeadly diseases.

Sterilization methods have been employed on reusable medical devices,including various endoscopes and steerable catheters, in an attempt todisinfect and eliminate viruses and bacteria for subsequent use of thedevices. For example, glutaraldehyde has been used to treat reusableendoscopes. Also, heat sterilization and other chemical disinfectionhave been employed to attempt to sterilize internally contaminatedmedical devices. Some endoscopes and steerable catheters contain verysmall and narrow working channels or lumens for performing intricatemedical procedures. These small or narrow working channels or lumens aredifficult to clean and sterilize. Further, research has shown that, inspite of attempts to sterilize endoscopes, endoscope lubricants canshield viruses, including HIV, from high-level disinfection. Diseasetransmissions have been documented for endoscopes used in diagnostic andsurgical procedures even after treatment with chemicals such asglutaraldehyde. The instances of epidemics of various diseases,including new and old diseases, are rising due to the increasing densityof human population and frequency of human contact. At the same time,the effectiveness of certain antibiotics is diminishing and the numbersof individuals with increased susceptibility to disease is on theincrease. Technological advances have also increased the frequency ofuse of medical instruments which are difficult to clean, yet are notdisposable. These factors have produced an environment where thelikelihood of infection caused by passing disease causing viruses,bacteria, or other matter is rapidly increasing.

In addition to the problem of infection and transmission of disease,prior endoscopes and catheters by virtue of their design and materialshave been intended for prolonged, repeated use. The precision ofmanipulation and movement in endoscopes and steerable catheters isessential for conducting the complicated medical procedures anddiagnostics generally employed by such devices. Some repeated useendoscopes and steerable catheters have contained steering mechanisms tomanipulate the endoscopes within the human body. These mechanisms havebeen complicated and required precision calibration. Further, thesedevices have also had to withstand sterilization with heat or chemicals.To accomplish these objectives, reusable endoscopes and steerablecatheters have been made of steel or other durable metals which arecostly.

To maintain integrity and precision, endoscopes and steerable cathetershave generally been designed as intended for repeated, prolonged use. Inspite of being designed for repeated use, however, these scopes such aslaparoscopes, require replacement much more frequently than othervisualization equipment such as cameras or light sources. A typicalreplacement cycle is one to two years. In high volume surgery centers,some scopes require replacement after a few weeks or months due todamage from mishandling or dropping. Repairing these endoscopes is alsocostly. The requirement of sterilization also adds additional cost toeach medical procedure requiring additional chemicals and equipment.

Limited attempts have been made to provide a detachable reusableendoscope. One repeated use detachable-end endoscope with a detachableflexible shaft is described in U.S. Pat. No. 4,911,148 by Sosnowski etal. titled "Deflectable-End Endoscope With Detachable Flexible Shaft."This patent describes a flexible shaft assembly which connects to ahandle subassembly to form an endoscope. The handle subassembly includesa hollow female bayonet connector which couples with a male connector inthe shaft subassembly. The endoscope described in U.S. Pat. No.4,911,148 by Sosnowski has a central opening extending from a proximalend to the distal end of the endoscope. A lens is positioned within theopening to provide appropriate magnification for an operator to manuallyview the distal end of the endoscope. This endoscope is also intendedfor reuse as both the shaft subassembly and handle subassembly areprovided with watertight seals to prevent a compromise of internalcomponents resulting from usage and sterilizations. The shaftsubassembly, however, as described above, has some of the sterilizationfailures of previous technology and provides an awkward and inefficientmanner for viewing the distal end of the endoscope.

In addition to the issues of disease transmission and disposability,numerous endoscopes have been designed which are bulky or difficult touse, requiring numerous hands or personnel. Hand-held catheters havebeen developed to provide the control and manipulation of the catheterfor simultaneous use with surgical tools, fiber optic scopes, and fluidsneeded for medical operations, such as in U.S. Pat. No. 5,342,299 bySnoke et al. titled "Steerable Catheter." Many medical procedures,however, require passage of relatively straight instruments into thehuman body at an angle difficult to actuate relative to the position ofthe portion of the medical device in the medical practitioner's hand.

As stated, none of the prior catheter or endoscope systems utilizedfiber optic imaging systems to view within a human body. These systemsrequired the use of an endoscope or catheter in conjunction with anexternal camera for transmitting images from within a human body to anexternal monitor. These external cameras occupied limited space in theoperating or examination rooms and were susceptible to breakage orcontamination. Still further, these cameras needed to be designed towithstand required direct sterilization.

Charged-coupled devices ("CCD's") have been proposed for use withendoscopes allowing direct image capture at the distal tip of anendoscope. Such systems conventionally place a camera chip at the distalend of a scope such as a laparoscope are referred to as a"chip-on-a-stick." These chip-on-a-stick devices are used in conjunctionwith an external camera connected to the scope by a cable. Thesechip-on-a-stick devices have several problems associated with them. Forexample, the scope may become contaminated during a procedure andsterilization often cannot be adequately performed on the device becauseof the presence of the CCD chip. This CCD chip also makes the scopesomewhat expensive, especially where contamination occurs andsterilization is not possible without damaging the chip.

In chip-on-a-stick systems, the chip-on-a-stick generally would not besusceptible to sterilization at the tip of the endoscope because thecamera chip is positioned on or around the tip. These external camerasalso require space in shipping and storage. Prior endoscopes orsteerable catheters which utilized fiber optic technology also often hadan external focus mechanism associated with the external camera. Thiswould require the practitioner to look or reach away from the area ofthe procedure to focus the image being viewed within the human body.

SUMMARY OF THE INVENTION

The present invention solves the aforementioned problems by providing asteerable catheter and methods including a reusable handle having a bodyand control means detachably connected to the interface of a disposablemodule which has an elongate tube including at least one lumen anddeflecting means to provide a steerable catheter having a disposablemodule and a sterilizable handle for inserting at least portions thereofinto a vessel, cavity, or tissue of a human body to thereby providemanipulation of a distal portion of the catheter when positioned withina vessel, cavity, or tissue. The present invention advantageouslyprovides a steerable catheter having a disposable module and asterilizable handle to eliminate or reduce the problem of diseasetransmission by providing a detachable steerable catheter including adisposable module designed for a single use which contains the difficultto sterilize working channels or lumens which can be utilized inconjunction with a reusable handle which can be effectively sterilizedafter each use. A detachable steerable catheter preferably includes amodule having an elongate tube which is disposable after each use.

The present invention also advantageously provides a detachablesteerable catheter having a module including an elongate tube having atleast one lumen within the tube with the module being easily detachablyconnected to a reusable handle which can be repeatedly sterilized toprovide a cost-effective medical device which greatly reduces thepossibility of transmission of disease from repeated use of the device.The present invention further advantageously provides a cost-effectivedisposable steerable catheter which retains the integrity and accuracyrequired during surgical uses. By providing a steerable catheter havinga disposable module and a sterilizable handle the cost-per-procedure isreduced, and a reusable, easily sterilized handle according to thepresent invention retains the necessary precision which instillsconfidence in the medical practitioner due to its construction andergonomic characteristics.

In accordance with the present invention, a steerable catheter having adisposable module and a sterilizable handle is provide for use in humanbody vessels, cavities, or tissue. The detachable steerable catheterpreferably includes a module including an elongate tube having at leastone lumen extending from a distal end to a proximal end of said tube, amodule interface connected to the proximal end of said tube, anddeflecting means connected to said tube for deflecting the distalportion of said elongate tube. The detachable steerable catheter furtherhas a handle detachably connected to the module and configured to bereadily held in the hand of a user. The handle preferably includes abody having a wall positioned in distal portions of the body. The wallhas an outer surface defining an exterior portion of the body. Thehandle also has a first cavity formed within the body. The body isdetachably and coextensively connected to the module interface throughthe outer surface of the wall. The handle also includes control meansconnected to the body and detachably connected to said deflecting meansof the module for responsively controlling the deflecting means tothereby manipulate distal portions of the elongate tube. The controlmeans and the deflecting means are connected to define a unitarycatheter manipulation means which extends from the first cavity, throughthe wall, and to the tube for manipulating a distal portion of thecatheter when positioned within a vessel, cavity, or tissue.

This steerable catheter having a disposable module and a sterilizablehandle is for inserting at least portions thereof into a vessel, cavity,or tissue of a human body to thereby provide manipulation of a distalportion of the catheter when positioned within a vessel, cavity, ortissue. In an illustrative embodiment, the outer surface of the wall anda lower surface of the module interface also detachably connect todefine a second cavity. The control means and the deflecting means aredetachably connected within the second cavity so that the unitarycatheter manipulation means extends from the first cavity, through thewall, through the second cavity, and to the tube for manipulating adistal portion of the catheter when positioned within a vessel, cavity,or tissue.

The present invention also includes methods of connecting and using acatheter. A method of detachably connecting a catheter having a handlewhich includes a body and a detachable module which includes an elongatetube having at least one lumen extending therethrough is provided by thepresent invention. This method preferably includes connecting afiberscope to a distal end portion of the body of the handle,positioning the fiberscope into the at least one lumen of the tube ofthe module, and connecting the module to the body of the handle forviewing portions of a vessel, cavity, or tissue when a distal end of thetube is positioned therein.

The catheter and methods of the present invention further provide adetachable catheter with a reusable fiber optic scope which can bedetachably connected to the handle and sealed within the detachablemodule during a medical procedure. A steerable catheter having adisposable module and a sterilizable handle according to the presentinvention also can advantageously be provided in a kit which, forexample, includes a plurality of detachable, disposable modules and areusable handle and fiber optic scope to be used with the disposablemodules. The handle of a steerable catheter having a disposable moduleand a sterilizable handle according to the present invention can furtherinclude an angled handle that provides entry to positions of the humanbody while allowing the medical practitioner to grasp the steerablecatheter in an advantageous hand position. A detachable steerablecatheter can also advantageously include a camera mounted internally inthe handle of the catheter wherein the handle can be sterilized with thecamera therein, and the camera is protected from breakage orcontamination therein. A steerable catheter and methods according to thepresent invention further can provide a steerable catheter having afocus means positioned on the handle of the catheter for focusing theinternal camera positioned within the handle. A steerable catheter andmethods of the present invention also advantageously provide adisposable module and a sterilizable handle having a focus wheel andcontrol wheel disposed such that the focus wheel and control wheel canbe simultaneously adjusted by the same hand of the practitioner.

BRIEF DESCRIPTION OF THE DRAWINGS

Some of the objects and advantages of the present invention having beenstated, others will become apparent as the description proceeds whentaken in conjunction with the accompanying drawings as follows:

FIG. 1 illustrates an environmental view of a medical procedure beingconducted on a patient using a steerable catheter having a disposablemodule and a sterilizable handle according to the present inventionpositioned within an opening in the urological region of a human body bya medical practitioner for a therapeutic treatment of a problem area;

FIG. 2 illustrates an environmental perspective view of a steerablecatheter having a disposable module and a sterilizable handle being heldby the hand of a medical practitioner while simultaneously controllingan imaging system and manipulating a distal end portion of the catheteraccording to an embodiment of the present invention;

FIG. 3A illustrates a perspective view of a steerable catheter having adisposable module and a sterilizable handle according to the presentinvention showing a fiber optic scope being detachably connected to thehandle;

FIG. 3B illustrates a perspective view of a steerable catheter having adisposable module and a sterilizable handle according to the presentinvention showing the fiber optic scope detachably connected to thehandle and the module being positioned to slide over the fiber opticscope to detachably connect to the handle;

FIG. 3C illustrates a steerable catheter having a disposable module anda sterilizable handle according to the present invention having adetachable connected fiber optic scope positioned within the module andhaving the module positioned to detachably connect to the handle;

FIG. 3D illustrates an exploded perspective view of an imaging interfaceincluding an imaging capture device and a fiber optic scope of asteerable catheter according to the present invention;

FIG. 4 illustrates an enlarged perspective sectional view of a steerablecatheter having a disposable module and a sterilizable handle accordingto the present invention showing a module interface of the module havingmedical instruments inserted within a lumen of the module;

FIG. 5 illustrates a cross-sectional view taken along line 5--5 of FIG.3B showing a module of a steerable catheter detached from a handleaccording to an embodiment of the present invention;

FIG. 6 illustrates a cross-sectional view taken along line 6--6 of FIG.3B showing a handle with a detachably connected fiber optic scope of adetachable steerable catheter according to the present invention havingan imaging cable detachably connected to the handle;

FIG. 7 illustrates a side view taken according to line 7--7 of FIG. 3Cshowing an embodiment of a steerable catheter according to the presentinvention having a module and a fiber scope detachably connected to ahandle with the fiber scope positioned within the module and having amedical instrument inserted within an access port and working lumen ofthe catheter;

FIG. 8 illustrates a top view taken along line 8--8 of FIG. 7 of asteerable catheter having a disposable module and a sterilizable handleaccording to the present invention showing a controller means detachablyconnected to a deflector of the module;

FIG. 9 illustrates a top view taken along line 9--9 of FIG. 7 showing animaging interface cable and a focus cable connected to a shaft of afocus wheel and a focus controller disposed within a handle of adetachable steerable catheter according to the present invention;

FIG. 10 illustrates a side view taken along line 10--10 of FIG. 8showing a steerable catheter having a disposable module and asterilizable handle according to the present invention including animaging system disposed within the handle;

FIG. 11 illustrates an enlarged cross sectional view taken along line11--11 of FIG. 3C illustrating working lumens, a fiber optic scopelumen, deflecting wires, and an outer circumference of an elongate tubeof a catheter according to the present invention;

FIG. 12 illustrates an enlarged fragmentary view of a distal portion ofa catheter according to the present invention illustrating the insertionof deflecting wires within the catheter and showing a top of an elongatetube in phantom view;

FIG. 13 illustrates a sealed disposable module of a detachable steerablecatheter according to the present invention for use in a kit; and

FIG. 14 illustrates a steerable catheter having a disposable module anda sterilizable handle forming a kit according to the present inventionincluding an individually packaged handle, fiber scope, and a pluralityof modules within a single secondary package for distribution.

DETAILED DESCRIPTION

The present invention now will be described more fully hereinafter withreference to the accompanying drawings in which preferred embodiments ofthe invention are shown. This invention may, however, be embodied inmany different forms and should not be construed as limited to theillustrated embodiments set forth herein; rather, these illustratedembodiments are provided so that this disclosure will be thorough andcomplete and will fully convey the scope of the invention to thoseskilled in the art. Like numbers refer to like elements throughout.

With further reference to the drawings, FIG. 1 illustrates anenvironmental view of a disposable steerable catheter 20 according tothe present invention being used by a medical practitioner or doctor Din a medical procedure on a human body B. This embodiment of adisposable steerable catheter 20 is for inserting at least portionsthereof into a vessel, cavity, or tissue of the human body B to therebyprovide manipulation of a distal portion of the catheter 20 therein andto perform medical procedures using this catheter 20. The detachable anddisposable steerable catheter 20 enables the medical practitioner D toinsert medical instruments and fluids into a human body B and to viewimages from therein. Medical, surgical, and diagnostic procedures can beperformed using a steerable catheter 20 having a disposable module 50and a sterilizable handle 30 according to the present invention.Particularly, FIG. 1 shows the insertion of a detachable steerablecatheter 20 according to the present invention into the urological canalduring surgery. Procedures in other regions of the body could alsoeffectively utilize the steerable catheter 20 having a disposable module50 and a sterilizable handle 30 according to the present inventionincluding procedures in the epidural region, the sinus cavity and/ornose region, the brain region, and other regions of the human body B.

As illustrated in FIGS. 3A-3D, the detachable steerable catheter 20according to the present invention has a handle 30 detachably connectedto a module 50. At least a distal portion 30a of the handle 30, andpreferably the distal portion 30a and a bulbous portion 30b, has abulbous shape. The handle 30 also is preferably configured to be readilyheld in the hand H of a user as shown in FIG. 2. More specifically, thedetachable steerable catheter 20 has a module 50 including an elongatetube 55 having at least one lumen 67, 68, 69 (FIG. 12) preferablyextending from a distal end portion 58 to a proximal portion 56 of thetube 55 as best shown in FIGS. 3B and 12. The module 50 also includes amodule interface 53 connected to the proximal portion 56 of the tube 55and deflecting means, e.g., deflector 60, associated with and preferablyconnected to the tube 55 for deflecting the distal end portion 58 of theelongate tube 55 as shown in FIGS. 5, 11, and 12. The deflecting means60 preferably includes a pair of steering wires 61, 62 positioned withinand coaxially extending the substantial length of the tube 55. It willbe understood by those skilled in the art, however, that other types ofdeflectors 60 may be used as well.

The handle 30 has a body 31 including a wall 32 positioned in distalportions of the body 31 as shown in FIG. 3A. The wall 32 has an outersurface 32a defining an exterior portion of the body 31 without themodule 50 connected thereto. The body 31 further includes a first cavity34 positioned within the body 31 as shown in FIG. 6. The body 31preferably is detachably and coextensively connected to the moduleinterface 53 through the outer surface 32a of the wall 32.

The handle 30 also has control means, e.g., controller 40, connected tothe body 31 and detachably connected to deflecting means 60 of themodule 50 as shown in FIGS. 7-10. The control means 40 is positioned toresponsively control the deflecting means 60 to thereby manipulatedistal end portions 58 of the elongate tube 55. The control means 40 anddeflecting means 60 are connected to define a unitary cathetermanipulation means, e.g., manipulator 80, extending from the firstcavity 34 through the wall 32 into the tube 55 for manipulating a distalend portion 58 of the catheter 20 when positioned within a vessel,cavity, or tissue of the human body B.

FIG. 7 illustrates an embodiment of a steerable catheter 20 having adisposable module 50 and a sterilizable handle 30 according to thepresent invention wherein the outer surface 32a of the wall 32 of thebody 31 and a lower inner surface 53a of the module interface 53 cometogether to form a second cavity 38. The control means 40 and deflectingmeans 60 are detachably connected within the second cavity 38 and to thetube 55 as shown in FIG. 7. The unitary catheter manipulation means 80extends from the first cavity 34 through the wall 32 and through thesecond cavity 38 into the tube 55 for manipulating a distal end portion58 of a catheter 20 when positioned within a vessel, cavity, or tissue.

As best illustrated in FIGS. 3A, 3B, and 3D, a fiber optic scope 90 isalso connected to an imaging interface 25 of an imaging system 24positioned in the body 31 of the handle 30. The imaging interface 25 ispreferably positioned within the second cavity 38 as shown in FIG. 10.The fiber optic scope 90 preferably is a fiber optic scope 90 used totransmit light from an external light source to within the human body Bto illuminate a vessel, cavity, or tissue as well as to receive imagescaptured within the human body B. The fiber optic scope 90 providedaccording to the present invention preferably is reusable and able to berepeatedly sterilized. Upon connection of the module 50 and handle 30,the second cavity 38 preferably is sealed by the connection of theperipheral edge portions 51 of the module 50 and the edge portions 37 ofthe handle 30. The connection of the fiber optic scope 90 to the imaginginterface is thus protected within this second cavity 38.

The handle 30 is also provided to be sterilized and used repeatedly. Thebody 31 of the handle 30 preferably is constructed of a suitablematerial which can withstand heat sterilization temperatures andchemical sterilization as understood by those skilled in the art. Thesesterilization methods are understood by those skilled in the art and,therefore, will not be discussed further. The handle 30 is alsoconstructed of a material which possesses structural properties whichallow for repeated detachable connection to a plurality of modules 50.Further, the material of the handle 30 facilitates the ergonomicadvantages of the handle 30 such that the handle 30 is light weight andable to be configured to be readily held in the hand H of a user. Thehandle 30 preferably is sealed along its exterior openings by seals suchas o-rings 39 as shown in FIG. 6 to protect the first cavity 34.

The module 50 preferably is intended to be disposed of after a singleuse. The module 50, including the module interface 53, is alsoconstructed of a material which possesses structural properties whichallow for detachably connecting the module 50 to the handle 30. Further,the module 50 is constructed of a material which is lightweight andallows for manipulation and deflection of the elongate tube 55 withinthe body 31. Also, the module 50 in its intended single-use capacity isalso provided of a material which can be cost effectively disposed ofafter a single use. As such, the elongate tube 55 is preferablyconstructed of suitable materials such as a thermoset or athermoplastic. The module interface 53 also is constructed of suitablematerials such as a thermoset or a thermoplastic. Although the handle 30and fiber optic scope 20 are preferably reusable, a detachable steerablecatheter 20 according to the present invention having a disposablehandle 30 or fiber optic scope 90 could be provided within the contextof the present invention.

Further, the embodiment of FIG. 2 is shown having a plurality of accessports 64, 65, 66 for inserting fluids or medical instruments within acatheter 20 and into a cavity, vessel, or tissue of the human body. Byway of example, FIG. 3C illustrates a tube 55 connected within an accessport 64 for introducing fluids into the human body B. FIG. 1 illustratesa medical instrument I being inserted through one of a plurality ofaccess ports 64, 65, 66 of the steerable catheter 20 having a disposablemodule 50 and a sterilizable handle 30 according to the presentinvention. Further, for example, the elongate tube 55 can also beprovided to include at least one lumen 67, 68 which extends from theproximal portion 56 toward the distal end portion 58 of the tube 55 asshown in FIGS. 5 and 12, but stops short of the end of the distal tip 59of the tube 55. This lumen 67, 68 can be utilized for supplying an airsupply for inflating a balloon for various procedures. The elongate tube55 can be sized having various outer diameters, a plurality of lumens,and lumens having various diameters and shapes.

The diameter of the elongate tube 55 depends on the end application ofthe detachable steerable catheter 20. In diagnostic visualization andfluid delivery applications, for example, a catheter 20 having anelongate tube 55 having an outer diameter of about 2 mm is preferable.With inserting instruments, suction, irrigation, or procedures utilizingballoons such as angioplasty, for example, an elongate tube 55 having anouter diameter of about 3 to 3.5 mm is preferable. In applicationsrelated to urology, for example, an outer diameter of about 2.5 to 3 mmis preferable for the elongate tube 55 of the detachable steerablecatheter 20 according to the present invention. The module 50 can alsohave different durometers and different port functions. As such thedetachable steerable catheter 20 according to the present invention isdesigned to facilitate ease of use in a single hand-held unit.

FIGS. 3A-3D illustrate a series of perspective views of a steerablecatheter 20 having a disposable module 50 and a sterilizable handle 30according to the present invention as well as of a method of detachablyconnecting this catheter 20. The detachable steerable catheter 20 ispreferably detachably connected as follows. First, a sterilized handle30 and a sterilized fiber optic scope 90 as described above areprovided. The handle 30 includes an imaging interface 25 which ispreferably connected within the body 31 of the handle 30 such that itextends from within the first cavity 34 of the body 31 through the wall32 of the body 31 as illustrated in FIG. 3A and FIG. 6. Preferably, theimaging interface 25 includes a female bayonet connector 26 includingopposite grooves 27a, 27b (not shown) for detachably connecting theimaging interface 25 to the proximal end 92 of the fiber optic scope 90.The fiber optic scope 90 includes a male bayonet connector 94 connectedto the proximal portion of the fiber optic scope 90. The imaginginterface 25 and fiber optic scope 90 connect in a male/female bayonetconnection as shown in FIG. 6. The fiber optic scope 90 includes flanges95a, 95b extending outwardly from opposite sides of the proximal femaleconnector 26 which mate with the grooves 27a, 27b in the image interface25 to perform the bayonet connection. Various other connectors couldalso be used as understood by those skilled in the art. The fiber opticscope 90 is detachably connected by sliding the fiber optic scope 90longitudinally onto the imaging interface 25 as shown in FIGS. 3A and3D. Other equivalent connections could be provided which would allow forthe fiber optic scope 90 to be easily detachably connected. Thisconnection provided, in the preferred embodiment, provides a connectionbetween the imaging bundle and the light source of the imaging interface25 which interacts with the fiber optics of the fiber optic scope 90.

With the fiber optic scope 90 detachably connected to the handle 30, adisposable module 50 as illustrated in FIG. 3B and described above isalso provided. The distal end 93 of the fiber optic scope 90 ispreferably coaxially aligned with a lumen 69 in the proximal end of themodule 50 as shown in FIG. 3B. The lumen 69 extends from the moduleinterface 53 through the elongate tube 55 to the distal end 59 of theelongate tube 55. The fiber optic scope 90 is slid longitudinallycoaxially within the lumen 69 toward the distal portion 58 of theelongate tube 55. The fiber optic scope 90 is sized to extendlongitudinally coaxially through the elongate tube 55 from the proximalportion 56 to the distal end portion 58 of the elongate tube 55 withinthis lumen 69. FIG. 3B shows the module 50 receiving the fiber opticscope 90 within the scope lumen 69 of the module interface 53.

Sliding the module 50 over the fiber optic scope 90 will generally alignthe module 50 and handle 30 to facilitate detachably connecting them.The module interface 53 and body 31 of the handle 30 are then detachablyconnected via connection means, e.g., connectors or mating peripheraledges 37, 51. For example, the connecting means could also include ribsand grooves located reciprocally on the module interface 53 and body 31.The module 50 may likewise have ribs on the upper proximal portion and alower proximal portion. These ribs may detachably connect to groovesconnected in the medial portion of the body 31 on an upper surface andon the distal portion on a lower surface of the body 31 with the moduleconnecting means and body connecting means with one comprising ribs andthe other comprising grooves whereby the ribs and grooves connect todetachably connect the module 50 to the body 31 of the handle 30. Asunderstood by those skilled in the art, other connecting means couldalso be used, such as snap fitting connectors. The connecting meanscould also be located in other portions of the module 50 or handle 30.

The module 50 and handle 30 are connected to provide various structuraladvantages as described below. Connecting the module interface 53 to thebody 31 of the handle 30 preferably will positionally locate or alignthe controlling means 40 of the handle 30 and the deflecting means 60 ofthe module 50 for detachably coupling them. The control means 40 and thedeflecting means 60 will be detachably connected utilizing a tap engager75 located on the module 50 as best illustrated in FIGS. 3C and 5. FIGS.3B, 3C, 5, and 6 show the steps of detachably connecting the module 50to the handle 30 and coupling the control means 40 of the handle 30 tothe deflecting means 60 of the module 50 to actuate manipulation of theelongate tube 55.

An imaging cable 89 preferably is then detachably connected into animage port 36 positioned in the proximal end 30b of the handle 30 asillustrated in FIG. 6. Although conventional male/female connectorspreferably are utilized, other connectors also could be utilized. Thesteerable catheter 20 having a disposable module 50 and sterilizablehandle 30 is thus detachably connected for use in the intended medicalprocedure. Once detachably connected, the detachable steerable catheter20 according to the present invention provides the medical practitionerwith the ability to deflect or manipulate the distal end portions 58 ofthe tube 55 within a human body B. The detachable steerable catheter 20also provides the practitioner D with the ability to focus images fromwithin the human body B using focus means 100 connected to the body 31of the handle 30 of the catheter 20. Further, the medical practitioner Dcan also insert fluids or medical instruments I into the human body Busing this catheter 20.

Upon completion of the medical procedure, the steerable catheter 20having a disposable module 50 and a sterilizable handle 30 according tothe present invention can be easily disconnected. In the preferredembodiment, the tap engager 75 is provided with a detachment knob 78 asshown in FIG. 5. The detachment knob 78 preferably is grasped andactivated by pulling, thereby breaking a connection within the module 50which allows the module 50 to detach from the handle 30. The handle 30remains equipped to be repeatedly sterilized and receive anothersterilized disposable module 50. The module 50 is slidably removed fromthe fiber optic scope 90 and disposed. The fiber optic scope 90 can thenbe disconnected in this embodiment by rotating the bayonet connectionand sliding the fiber optic scope 90 off the imaging interface 25. Themodule 50 is preferably discarded, while the fiber optic scope 90 andhandle 30 are preferably sterilized for reuse. The imaging cable 89 canbe disconnected by unplugging from the port 36.

The detachable connection between the handle 30 and the module 50provides structural advantages over prior steerable catheters. Forexample, in the embodiment of the detachable steerable catheter 20 asillustrated in FIG. 1, the elongate tube 55 will not rotate relative tothe handle 30 during manipulation of the tube 55 within a human body B.FIG. 7 shows the detachable steerable catheter 20 where the body 31 ofthe handle 30 has body connecting means, e.g., peripheral edge 37,connected to a medial portion on one surface and a distal portion on anopposite side of the body 31 for detachably connecting to the moduleinterface 53. The module interface 53 includes interface connectingmeans, e.g., peripheral edge 51, connected to the proximal portion ofthe module 50 for detachably connecting to the body 31. In FIG. 7, theconnecting means is detachably connected to the body connecting means inmedial and distal portions of the body 31 such that the body 31 and themodule interface 53 define a unitary structure having sufficientstability such that the module 50 remains connected to the handle 30 andthe tube 55 does not rotate relative to the handle 30 when the tube 55is manipulated within the human body B. This stability of the connectionis provided by the design of the module 50 and handle 30.

The module connecting means 51 detachably connects to the bodyconnecting means in the medial portion 30c of the body 31 of the handle30. The proximal portion of the module interface 53 coextensivelyoverlies the body 31 from the distal portion 30a of the body 31 to themedial portion 30c of the body 31 such that the module 50 remainsconnected to the handle 30 and the tube 55 does not rotate relative tothe handle 31 during manipulation of the tube 55 within the human body Bas shown in FIGS. 5 through 7. This embodiment has an upper proximalportion of the module 50 overlying the body 31 of the handle 30 todetachably connect at the medial portion of the upper surface of thehandle 30 as shown in FIGS. 5 to 7. Other embodiments, however, could beprovided with a module 50 extending in a lower or side portion tooverlie the body 31 to provide similar structural stability when thetube 55 is manipulated in the human body B. The tube 55 can be rotated360° about the longitudinal axis defined by the tube 55 by thepractitioner rotating the handle 30. As such, the tube 55 can contactthe body 31 in various angles and directions further requiring a secureand stable connection. This connection gives the advantage of having themodule 50 extend to the medial portion 30C of the body 31 providingstability for the connection. When the tube 55 is manipulated within thebody 31, torque can be transferred from the tube 55 to the handle 30.

The shape of the detachable steerable catheter 20 having an elongatetube 55 and handle 30 concentrates stress at the point where the tube 55and handle 30 connect. For example, the tube 55 could break off or crackif the two components, the module 50 and handle 30, were not securelyconnected. Further, if the connection were not strong enough, the forceand torque caused by manipulation would break the connection such as ifthe tube 55 was connected to a small portion of the distal end 30a ofthe handle 30. The connection described also contains many otherstructural advantages and advantages of ease of use, e.g., ready andease of assembly.

Further, the module interface 53 preferably has non-uniform proximaledge portions 51 as illustrated which define the proximal end 53a of themodule 50 as shown in FIGS. 3B and 3C. The body 31 of the handle 30preferably has non-uniform edge portions 37 and a wall 32 whichpreferably transversely extends across the handle body 31. Thenon-uniform proximal edge portions 37 of the module interface 53detachably connect to and mate with the non-uniform edge portions of thewall 32 and body 31 of the handle 30 to define a non-uniform continuousboundary between the module 50 and the handle 30 whereby the module 50is stabilized relative to the handle 30 during manipulation of the tube55 within a human body as shown in FIGS. 3A-C and FIG. 2.

For added stability, the module 50 as illustrated in FIGS. 2 and 3C alsoextends in its upper proximal portion in a lateral direction across thebody 31 of the handle 30. The lateral portion extends at a width greaterthan the width of the elongate tube 55 such that the module 50 remainsconnected to the handle 30 and the tube 55 does not rotate relative tothe handle 30 during manipulation of the tube within the human body. Thetube can be rotated laterally in a single plane by the deflecting means60 connected within the elongate tube 55. The entire handle 30 can alsobe rotated with the tube 55 deflected to rotate in a 360° plane, but foradded stability may also only be deflected in a 180° plane. During thismovement, stability is needed in the connection between the module 50and the handle 30.

As described above, in reference to FIG. 2, the detachable steerablecatheter 20 according to the present invention further has controllingmeans 40 for controlling portions of the tube 55 within a cavity,vessel, or tissue of a human body. The control means 40 preferablyincludes a control wheel 41 which can be rotated to activate controlconnector means for controlling the deflecting means 40 to manipulatethe portions of the tube 55 within a human body B. The body 31preferably has a recessed portion 23 formed in the outer surface asshown in FIG. 3A. The control wheel 41 preferably is connected in thisrecessed portion 23 for ease of handling and control. As shown in FIG.6, the control wheel 41 is substantially positioned within this recessedportion 23 such that the top surface 42 of the control wheel 41 alignswhile the horizontal plane of the outer surface of the body 31 forms aunitary horizontal plane. The control wheel 41 is also attached withinthe recessed portion 23 of the body 31 of the handle 30 at a levelwhereby the control wheel 41 can be rotated with the fingers of the handholding the catheter body as shown in FIGS. 1 and 2. The control wheel41 is connected to the handle 30 on the lower interior surface of thefirst cavity 34 of the handle 30. This control wheel 41 is positioned sothat it may be easily manipulated by the medical practitioner with thehand H which holds the catheter body 31. As illustrated in FIG. 7, thecontrol wheel 41 is rotatably and fixedly connected to the recessedportion 23 of the body 31 for controlling the deflecting means 40 tothereby manipulate distal portions 58 of the elongate tube 55 within ahuman body B. The control means 40 further has control connector meansconnected to the control wheel 41 and detachably connected to thedeflecting means 40 for connecting the control wheel 41 to thedeflecting means 40.

The control wheel 41 is generally circular in shape and has a topsurface 42 and a bottom surface 43. The wheel 41 preferably isconfigured to include an indented portion formed on each oppositevertical side of the control wheel 41 for manipulating the control wheel41. The indented portions 44 are shaped to receive a practitioner'sfinger F for rotating the control wheel 41 to manipulate portions of theelongate tube 55 within a human body. Preferably, the control wheel 41is rotated between a thumb and third finger when the wheel 41 is held inthe user's hand as best shown in FIGS. 1 and 2.

The control connector means 40 has deflection linkage wires 81, 82 eachrespectively connected to a shaft collar 46 of the control wheel 41. Thecontrol connector means further has deflection control pins 83 connectedto the deflection linkage wires 81, 82 at a distal portion thereof. Thedeflection control pins 83 extend from the first cavity 34 through thewall 32. The deflection control pins 83 are detachably connected to thedeflecting means 40 of the module 50. The control connector meanspreferably also has deflection springs 84 connected circularly andlongitudinally around a medial portion of the deflection control pins83. The control connector means allows the control wheel 41 to actuatethe deflection linkage wires 82, the deflection linkage control pins 83,and the deflection springs 84 to control the deflecting means 40 so asto manipulate a portion of the elongate tube 55 within the body 31.

The control wheel 41 preferably includes a shaft 49 connected to thebottom surface 43 of the wheel 41 at a center axis 45 of the wheel 41and extending laterally downwardly within the body 31 of the handle 30as shown in FIG. 7. The shaft 49 is rotatably connected to the body 31and fixedly connected to the control wheel 41 such that the shaft 49rotates in unison with the wheel 41 as it rotates. The control wheel 41illustrated in FIGS. 7-10 further includes the shaft collar 46 extendinglongitudinally toward the proximal direction of the handle 30. The shaftcollar 46 includes a groove or an opening 48 as illustrated.

The deflection linkage wires 81, 82 preferably are fixedly connected tothe shaft collar 46 of the control wheel 41 within the groove or opening48. The deflection linkage wires 81, 82 extend around the control wheel41 and toward the distal portion of the handle 30 and are fixedlyconnected to the proximal end of the shaft collar 46. The deflectionlinkage wires 81, 83 are connected in this embodiment and each includesa hooked portion 86 extending through and around an opening 88 in theproximal portion of the deflection control pins 83. The deflectioncontrol pins 83 preferably are connected to the deflection linkage wires81, 82 and control wheel 41 within the first cavity 34 of the body 31.The deflection control pins 83 are disposed horizontally and extendtoward the distal end portion 30a of the body 31. The deflection controlpins 83 extend from within the first cavity 34, through the wall 32 ofthe body 31, and into the second cavity 38 as shown in FIG. 6. Sealssuch as o-rings 39 preferably are positioned around each deflectioncontrol pin 83 between the pin 83 and the wall 32 to seal this openingfrom fluids and contaminants during use or sterilization.

Disposed around the deflection control pins 83 are the deflectiontension springs 84 also illustrated in FIG. 6. The deflection tensionsprings 84 interact with the wall 32 of the body 31 thereby providingresistance when the control wheel 41 is turned to actuate deflection ofthe tube 55. The detachable steerable catheter 20 according to anembodiment of the present invention shown in FIG. 8 thereby includes apair of these deflection control connector systems including the shaftcollar 46 of the control wheel 41, deflection linkage wire 82,deflection control spring 84, and deflection control pin 83 as shown inFIG. 8. This pair of deflection linkage wires 82, deflection tensionsprings, and deflection control pins 83 are disposed on each side of thelongitudinal axis of the body 31 shown in FIG. 8. The deflection controlpins 83 each contain an opening 89 in the distal portion of the controlpin 83 to receive the deflection means 40. The opening 89 laterallyreceives a steering wire end 73 located in the module 50.

The handle 30 preferably is sealed in all openings. The openings wherethe control wheel 41 and focus wheel 100 protrude from the body 31 alsoare sealed. In the embodiment of the present invention shown in FIGS.7-10, O-rings 48a are located between the control wheel 41 and the bodyedge portions and between the focus wheel 100 and the body edge portionsfor sealing the handle body 31 during use and sterilization. O-rings 39are also positioned around the opening in the wall 32 of the body 31where the deflection control pins 83 extend through the wall 32 of thebody 31 portion shown in FIG. 7.

The detachable steerable catheter 20 according to the present inventionfurther includes deflecting means 60 connected within the module 50.These deflecting means 60 are shown in FIGS. 8-12. The embodimentillustrated in these figures shows the deflecting means 60 comprisespairs of steering wires 61, 62 having distal portions connected to thedistal portions of the elongate tube 55 and proximal portions connectedto the module interface 53. As the steering wires 61, 62 preferably areidentical, they will be described in reference to one steering wire 61or 62 where appropriate. The proximal portions of the steering wires 61,62 preferably are positioned along a proximal portion of the moduleinterface 53. The module interface 53 is detachably connected to thebody 31 such that proximal ends 73 of the steering wires 61 62 aredetachably connected to the control means 40 to thereby manipulatedistal end portions 58 of the distal elongate tube 55 positioned withina human body B when the control means 40 are operatively activated.

As shown in FIG. 4, the steering wires 61, 62 extend from the lumen 67of the module 50 and each includes a steering wire end 73. The steeringwires 61, 62 preferably are positioned generally parallel to one anotherin the module 50. The steering wire ends 73 preferably are positioned onopposite sides of the scope lumen 69 of the tube 55. The steering wireends 73 include a leg 71 which extends laterally from the moduleinterface 53 and a post 54 disposed at the lateral edge portion of thesteering wire end 73. The post 54 extends downwardly so that when themodule 50 and handle 30 are detachably connected, the post 54 is alignedto be received within the opening 89 of the deflection control pin 83.

FIGS. 11 and 12 illustrate the portions elongate tube 55 of thesteerable catheter having a disposable module and a sterilizable handleand the construction of the steering wires 61, 62. The steering wires61, 62 extend through wire lumens in the elongate tube 55 to the distalend portion 58 of the elongate tube 55. In the distal end portion 58 ofthe tube 55, the steering wires 61, 62 are looped and extend parallel toeach other in an upper and lower portion of the tube 55 as shown in FIG.12. FIG. 12 is an enlarged cross-sectional view illustrating theinsertion of the steering wires 61, 62 prior to the forming of the tip(illustrated in phantom view) of the distal end portion 58 of the tube55. Pairs of upper steering wire lumens and lower lumens are positionedon opposite sides of the working lumens 67, 68 and scope lumen 69 withinthe tube 55 as shown in FIG. 11. The steering wires 61, 62 are insertedinto the wire lumens of the various portions of the tube 55 and formloops in the distal end portion 58. The steering wires 61, 62 preferablyare fixed to the elongate tube 55 so that the movement of the controlwheel 41 responsively moves the steering wires 61, 62 to thereby bendand manipulate the tube 55. Numerous techniques can be used to fix thesteering wires 61, 62 to the elongate tube 55 such as RF welding orwelding ends of the wires 61, 62 to a portion such as the distal portion58 of the elongate tube 55.

These techniques are understood by those skilled in the art. Asillustrated in the embodiment of FIG. 12, the looping of the steeringwires 61, 62 through the wire lumens of the distal end portion 58 of thetube 55 secures the steering wires 61, 62 to a portion of the elongatetube 55 and also reduces the slippage of the steering wires 61, 62 asthe steering wires 61, 62 are moved longitudinally with respect to oneanother to manipulate the various portions of the elongate tube 55. FIG.11 illustrates the location of the working lumens 67, 68, the scopelumen 69, and the steering wire lumens extending parallel to the axis ofthe coaxial proximal medial and distal portions and the steering wires61, 62 positioned within the elongate tube 55.

As the control wheel 41 is actuated in one direction and thereby movesthe control connector means in the same direction, the steering wires61, 62 are moved to deflect the elongate tube 55 under tension in thatdirection. The tube 55 can be deflected in an arced path along about a180° path. Various deflecting means other than steering wires 61, 62positioned in the elongate tube 55 are known and could be incorporatedwithin this embodiment of the detachable steerable catheter 20 asunderstood by the present invention.

The embodiment shown in FIGS. 5-20 further illustrates a module 50including an engaging means 75 for detachably engaging the deflectingmeans 60 of the module 50 and the control means 40 of the handle 30after the module 50 is detachably connected to the handle 30. Thisengaging means preferably is pivotally connected to the module interface53. The engaging means is movable between a first disengaged positionand a second engaged position. In the first disengaged position, theengaging means is not in contact with the deflecting means 60, and thedeflecting means 60 and the control means 40 are not detachablyconnected as illustrated in FIG. 5. Therefore, in the first disengagedposition, the distal end portion 58 of the elongate tube 55 cannot bemanipulated by actuating the control means 40.

In the second engaged position, the engaging means 75 guides or movesthe deflecting means 60 to detachably connect to the control means 40.The engaging means 75 is pivotally moved to the second engaged positionwhereby the engaging means 75 engages the deflecting means 60 anddetachably connects the deflecting means 60 to the control means 40 suchthat the control wheel 41 can be actuated to control the deflectingmeans 40 for manipulating the distal portion of the tube 55 in the humanbody B.

As shown in FIG. 5, the engaging means 75 preferably has a tap 79including a grip portion 75, 78 and an arm portion 74 hingedly connectedto the module interface 53. In the unengaged position, the arm portion74 is not in contact with the steering wire ends. The arm portion 74,however, is positioned such that when the grip portion 78 is grasped andthe tap 79 is pivoted, the arm 74 moves in a generally downwarddirection toward the center of the opening 89. The arm portion 74engages the steering wire end 73 and forces the post 54 of the steeringwire end 87 into the opening 89 of the control pin 83 as shown in FIGS.7 and 8. When the tap 79 is fully extended, a detachable lockingconnection is formed between an edge portion of the tap 79 and an edgeof the outer surface of the module 50 forming a single planar surfacewhich preferably seals the module 50 from exposure to fluids, viruses,bacteria, and other elements.

The module 50 is provided with a tap 79 constructed of a suitablematerial for rotating from the disengaged to the engaged positiondescribed herein. Preferably, this portion of the module 50 isconstructed from a flexible plastic which pivots without cracking orbreaking. The tap 79 is integrally formed with the module 50. In theengaged position as shown in FIG. 8, the steering wire posts 54 aredetachably connected within the openings 89 of the control pin 83. Asfurther shown in FIG. 7, the steering wire ends 73 remain detachablyconnected within the openings 89 of the control pin 83 by the lockingconnection of the tap 79 with the edge of the outer surface of the body31.

As such, the control wheel 41 can be rotated to deflect and manipulateportions of the elongate tube 55 within the human body B. As described,deflection of the distal end portion 58 of the elongate tube 55 occursin a horizontal plane of 180° rotation. Manipulation can be actuatedrotatably in vertical arc of 360° about the longitudinal axis of thetube 55 by rotating the hand H holding the handle 30 in either aclockwise or counterclockwise direction.

As shown in FIGS. 2 and 3A-C, the detachable steerable catheter 20according to the present invention has a module interface including anupper proximal portion which connects to the medial portion 30C of thehandle body 31. The module 50 includes a plurality of access ports 64,65, 66. The ports are connected within the upper proximal portion andpositionally aligned with at least one of the lumens 67 in the elongatetube 55 for accessing at least one lumen 67 therefrom. The tube 55 hasat least one lumen 67 which extends from the proximal end portion 56 ofthe elongate tube 55 to the distal end portion 50 of the tube. Theelongate tube 55 has an opening 96 in the distal end portion shown inFIG. 12. At least one lumen 67 is coaxially aligned with an opening inthe distal tip 96 of the elongate tube 55 defining at least one, andpreferably two or more, open channel extending from the access ports 64,65, 66 through the lumen 67 into the opening for inserting fluids andinstruments into the human body B.

The embodiment of the steerable catheter having a disposable module anda sterilizable handle according to the present invention as illustratedin FIGS. 2 and 3A-3D includes three access ports 64, 65, 66 positionedin the upper surface of the module interface 53. These access ports 64,65, 66 are positionally aligned with two lumens 67, 68 definingrelatively straight channels whereby medical instruments I and fluidscan be inserted through the access ports 64, 65, 66 into the lumen 67,68 extending substantially straight from a user toward a distal endportion 58 of the tube 55.

FIG. 3B, for example, shows this straight channel formed from the accessport into the lumen. The embodiment shown in FIG. 3B in combination withFIGS. 4 and 11 show three access ports 64, 65, 66 going through amanifold 120, best illustrated in FIG. 4, into two upper lumens 67, 68as shown in FIG. 11. The catheter 20 according to the present inventioncan be provided with various numbers of access ports 64, 65, 66 andlumens 67, 68, 69. Further, the catheter 20 can be provided without amanifold 120 having equal numbers of ports and lumens. The catheter 20according to the present invention, however, preferably has at least oneworking lumen 67 or 68 and one scope lumen 64 for the fiber optic scope90.

As shown in FIG. 3B, various attachments such as a fluid tube 132 with astandard medical luer lock 134 attached to its distal end can beconnected within an access port 64 such that a medical device orapparatus such as an IV fluid tube can be connected to the luer lock 134and inserted into the access port 64 and the elongate tube 55.

As shown in FIG. 4, the module 50 includes a module interface 53 havinga manifold 120 whereby piping connectors 122, 123, 124 extend from theaccess ports 64, 65, 66 into the lumens 67, 68 of the tube 55. FIG. 4shows three upper lumens 122, 123, 124 for inserting fluid and/orinstruments. FIG. 4 further shows a scope lumen 69 located below theworking lumens 67, 68 for inserting a fiber optic scope 90 within theelongate tube 55. A preferred embodiment contemplates a module 50 havinga manifold 120 positioned within the module 50. The manifold 120includes a piping connector 121 having a plurality of openingsconnecting a plurality of the access ports 64, 65, 66 to at least one ora lesser number of the lumens 67, 68 of the elongate tube 55. The accessports 64, 65, 66 and the lumens 67, 68 are positionally aligned onopposite ends of the openings of the piping connector 121 defining arelatively straight channel whereby medical instruments I and fluids canbe inserted through the access ports 64, 65, 66 into the lumen 67, 68extending substantially straight from a user toward a distal end of thetube 55.

The module 50 is further provided with an upper face which includes arecessed portion 59. The access ports 64, 65, 66 preferably arepositioned in an opening in the module interface 53 within this recessedportion as illustrated. In a preferred embodiment, as shown in FIG. 3B,the outward openings of the access ports 64, 65, 66 align with the uppersurface of the recessed portion 59 defining a generally unitary planebetween the access port openings and the surface of the recessed portion59 of the upper face. The position of these access ports 64, 65, 66 inthis recessed portion 59 is advantageous for inserting both medicalinstruments I and fluids as well as attaching a medical device orapparatus and connectors such as the tube 132 with luer lock 134 shownin FIG. 3B.

The catheter 20 according to the present invention is provided in apreferred embodiment with an angled handle 30. The catheter 20 includesa handle 30 detachably connected to the module 50 and configured to bereadily held in the hand H of a user. The handle 30 has a body 31including proximal 30b, medial 30c, and distal 30a portions. The body 31preferably angles, as shown in FIG. 6, from the proximal portion towardthe distal portion along an upper surface and a lower surface of thebody 31. This angling of the handle defines an angle θ, e.g., preferablybetween 5°-60°, between the tube 55 and the portion of the body 31 heldby the medical practitioner for facilitating inserting the catheter 20into a vessel, cavity, or tissue of the human body.

Various surgical and diagnostic procedures require inserting thedetachable steerable catheter 20 into openings at various angles. Theangled handle 30 facilitates the medical practitioner's ability tomaintain his hand, wrist, and forearm in an advantageous straightalignment allowing the angle of the handle 11 to position the tube 55within the opening. This facilitates both the ease and precision of use,as well as comfort for the patient and practitioner. Also, this anglingprovides other ergonomic advantages such as reducing fatigue on thepractitioner during lengthy or repeated procedures. Various angledconfigurations could be provided having the ergonomic advantages of thepreferred embodiment.

Other ergonomic advantages are provided by the catheter 20 according tothe present invention. For example, the distribution and weight of thecatheter 20 according to the present invention is such that it caneffectively be used as a single hand-held unit. The angling and weightdistribution of the catheter also enhance the usability of the controlwheel 41 and focus wheel 100. The catheter 20 according to the presentinvention is designed such that the focus wheel 100 and control wheel 41can be simultaneously activated to manipulate the elongate tube 55 asillustrated in FIG. 2.

Further, the detachable steerable catheter 20 according to the presentinvention, as illustrated in FIG. 8, comprises a body 31 includingvertical sides. The body 31 tapers inwardly from the distal portion 30atoward a medial portion 30c along the vertical sides and from a proximalportion 30b toward a medial portion 30c along the vertical sides. Thistaper also facilitates holding and manipulation of the detachablesteerable catheter 20 by a single hand. The embodiment illustratedincludes a narrow portion enabling the practitioner to grip the handle30 around the medial portion 30c between the thumb and fingers torotatively control the control wheel 41.

The handle 30 is also provided to be held near the medial portion 30c ofthe body 31 with the weight distribution such that the handle 30 remainsbalanced within the practitioner's palm during use. Such a longinstrument as the catheter 20, if not balanced, would tend to flop in aforward or rearward direction out of the practitioner's hand during use.Further the catheter 20 is lightweight. The handle 30 materialpreferably includes a thermoplastic or a thermoset or a metal/metalalloy (such as aluminum or stainless steel). Various other angled handle11 configurations could be provided with the described ergonomicadvantages.

The steerable catheter having a disposable module and a sterilizablehandle according to the present invention also has imaging means 150positioned within the body 31 of the handle 31 for transmitting imagesfrom within the human body B to an external viewing apparatus such as amonitor or CRT as shown in FIGS. 3A-3D and 7-10. The medicalpractitioner can thereby view a space within the human body B whilesimultaneously conducting medical procedures or diagnosis.

FIG. 7 illustrates a steerable catheter 20 having a disposable moduleand a sterilizable handle according to the present invention with animaging cable 89 detachably connected to the imaging means 150, such asan internally disposed camera 156 and internal interface cable 157,through an opening or port 36 in the proximal end portion 30b of thehandle 30. The imaging cable 89 extends outwardly from the catheter 20and connects at its opposite end to a viewing monitor or CRT as known inthe art for transmitting images from within the human body for viewingon the attached monitor.

An embodiment of the detachable steerable catheter 20 according to thepresent invention preferably includes imaging means which includes acamera 156 positioned within the first cavity 34 of the body 31 of thecatheter 20 for capturing and transmitting images from within the bodyas illustrated in FIGS. 7-10. The handle 31 is sealed to protect thecamera 156 from contaminants. The camera 156 also is sealed to withstandsterilization and use without damaging the camera. Although notpreferable, other imaging means such as an external camera could be usedin conjunction with the detachable steerable catheter 20 to capture andtransmit images from within the human body during the medical procedureaccording to the present invention.

The imaging interface cable 157 includes an image bundle and lightsource bundle. The imaging interface cable 157 connects to the proximalportion of the camera 156 and extends rearwardly around the shaft 49 ofthe focus wheel 100 and control wheels 41 as illustrated in thefragmentary sectional view of FIG. 9. The imaging interface cable 157extends further rearwardly and connects to the image connector 159positioned in the image port located in the proximal opening of thehandle 31 as shown in FIG. 7. This image connector connects to theexternal imaging cable 89 which includes a corresponding light sourceand image bundle for transmitting images from within the human body B tothe external monitor.

The imaging interface 25 preferably is connected to the distal end ofthe camera 156. The imaging interface 25 preferably extends through thewall 32 of the body 31. As illustrated in FIG. 8, the camera 156 isdisposed within the proximal portion of the handle body 31 and withinthe first cavity 34. The camera 156 is also disposed between the controlconnector means as also shown in FIG. 8. The camera 156 extendsrearwardly toward the medial portion of the body 31. The imaginginterface cable 157 extends rearwardly around the shaft 49 of thecontrol wheel 41 to connect with the image cable 89 in the proximalopening 36 of the detachable steerable catheter 20 as illustrated inFIG. 9.

A preferred embodiment of the steerable catheter 20 having a disposablemodule and a sterilizable handle according to the present invention isutilized with a fiber optic scope 90 as described in connection withFIGS. 3A through 3D. Other means of projecting light or receivingimages, however, could also be provided. Fiber scopes of varyingdimensions can be provided to match various sized elongate tubesutilized for different procedures. The fiber optic scope 90 provided ispreferably between 8 and 14 inches in length. In a preferred embodiment,such as illustrated in Figure G, the fiber optic scope 90 connectionwith the imaging interface 25 aligns the fiber optic material, e.g.,along flange 94a, of the fiber optic scope 90 with the light sourcebundle and camera 156 connected to the handle imaging interface. Thefiber optic scope 90 comprises a portion of fiber optic material whichis centered on the camera 156. The fiber optic scope 90, or fiber scope,is also aligned with light sources within the imaging interface. Thefiber scope 90 magnifies the light transmitted down the length of theelongate tube 55 from the light source. Further, the fiber optic scope90 receives images from within the human body B and transmits them tothe camera 156 connected to the fiber optic scope 90.

In conjunction with the imaging means of a preferred embodiment, thedetachable steerable catheter 20 also has focus means 100 for focusingimages transmitted from within the human body during a medical procedureor diagnosis. This focus means 100 preferably includes a focus wheel 101having a top surface and a bottom surface whereby images are easilyadjusted or focused using a single finger F to rotate the top surface ofthe wheel 101 as shown in FIG. 2. The focus wheel 101 includes anindentation 104 configured to receive a finger F as shown in FIGS. 2 and3 for rotating the focus wheel 101 to focus images transmitted fromwithin the human body. The medical practitioner can thereby easily focusthe images transmitted from within the human body on the catheter 20while viewing the images on the attached monitor.

The focus wheel 101 preferably is positioned on the upper surface of thebody 31 in proximity to the deflecting control wheel 41 such as tofacilitate focusing and controlling by a single hand H of thepractitioner or by another practitioner. The catheter 20 according tothe present invention overcomes prior problems of focusing an externalcamera requiring moving away from the space of the actual procedure orrelying on another practitioner or assistant for focusing.

The focus means 100 further includes a focus connector fixedly connectedto a bottom surface of the focus wheel 101 such that the shaft 108 andthe focus wheel 101 rotate in unison (see FIG. 9). The shaft 108 extendsdownwardly within the first cavity 34 of the body 31 and is connected tothe body 31 on the bottom of the body 31.

The control wheel 41 contains a recessed center portion of the uppersurface. The focus wheel 101 is positioned concentrically within thisrecessed portion of the control wheel 41 as illustrated in FIG. 10. Thefocus wheel 101 is connected to the body 31 in the recessed portion ofthe control wheel 41 such that the focus wheel 101 and the control wheel41 define generally concentric circles and are aligned defining agenerally common center portion of each wheel with the imaging focuswheel 101 having a smaller diameter than the control wheel 41. The focuswheel 101 and control wheel 41 rotate independently. Various othershapes and configurations of this catheter 20 having a focus wheel 101according to the present invention could be provided. The upper surfaceof the focus wheel 101 and the control wheel 41 preferably form aunitary plane.

FIGS. 7, 8, 9, and 10 illustrate other aspects of an embodiment of thefocusing means. The focusing means further comprises, in thisembodiment, a focus cable 109 connected to the shaft 108 of the focuswheel 101. The camera 156 includes an imaging focus means which whenactuated by rotating the focus wheel 101 rotates to focus the images.This allows the focus wheel 101 to be rotated beyond a full 360° in asingle direction to facilitate focusing. Preferably, when the focuswheel 101 is turned beyond about 15-30°, e.g., about 22.5°, for example,the image is inverted and the imaging means continues to focus the imageas viewed. FIG. 9 shows the focus cable 109 connected to the shaft 108of the focus wheel 101 for translating the rotational movement of thefocus wheel 101 into linear movement of focusing a focus cell or othermeans within the cavity 34 for focusing the image.

The steerable catheter having a disposable module and a sterilizablehandle according to the present invention can also be supplied inanother embodiment as a catheter kit 200. The detachable steerablecatheter kit 200 provides a catheter 20 for inserting at least portionsinto a vessel, cavity, or tissue of the human body B to thereby providedisposability and manipulation of a portion of the catheter 20 whenpositioned within the vessel, cavity, or tissue. The kit 200 comprises aplurality of disposable modules 50 and a reusable handle 30 fordetachably connecting to the modules 50. The handle 30 is configured tobe readily held in the hand H of a user as described above.

The detachable steerable catheter kit 200 further comprises a fiberoptic scope 90 which can be detachably connected to the handle 30 andpositionable within the module 50 as previously described. The module 50of this kit 200 would include an elongate tube 55 having at least onelumen 67, 68 extending from a distal end 58 to the proximal end 56 ofthe tube 55, a module interface 53 connected to the proximal end 56 ofthe tube 55, and deflecting means 60 connected to the tube 55 fordeflecting the distal portion of the elongate tube 55. The reusablehandle 30 has a body 31 including a wall 32 positioned in distalportions of the body 31; the wall 32 has an outer surface thereofdefining an exterior portion of the body 31. A first cavity 34 is formedwithin the body 31. The body 31 is detachably and extensivelyconnectable to the module interface 53 through the outer surface of thewall 32. The handle 30 also has control means 40 connected to the body31 and detachably connected to the deflecting means 60 of the module 50for responsively controlling the deflecting means 60 to therebymanipulate distal portions of the elongate tube 55. The control means 40and deflecting means 60 define a unitary catheter manipulation meansextending from the first cavity 34 through the wall 32 and to the tube55 for manipulating a distal portion of the catheter 20 when positionedin a vessel, cavity, or tissue.

This catheter kit 20 is illustrated in FIGS. 13 and 14. FIG. 13illustrates a module 50 as described above sealed within a plasticpackaging. FIG. 14 illustrates a plurality of these disposableindividually sealed modules 50 inserted within a package with a sealedreusable handle 30 and a sealed reusable fiber scope 90 both asexplained previously. Other configurations of the kit 200 can be sold.For example, a kit can be sold without a fiber scope 90 or with aplurality of varying sized fiber scopes 90 and modules 50. As indicated,the fiber optic scope 90 and module 50 vary in length, diameter, andconfiguration according to the end application. This kit 200 willfacilitate ease of use as a catheter 20 and included camera 156 whichcan all be shipped, stored, and used in a small space. The catheter kit20 according to the present invention also provides the advantage ofsaving space such as during shipping, storage, and use.

The present invention also includes methods of connecting and using acatheter 20 as described above and as illustrated in the drawings. Amethod of detachably connecting a catheter 20 having a handle 30 whichincludes a body 31 and a detachable module 50 which includes an elongatetube 55 having at least one lumen 67, 68, 69 extending therethrough isprovided by the present invention. This method preferably includesconnecting a fiberscope 90 to a distal end portion of the body 31 of thehandle 30, positioning the fiberscope 90 into the at least one lumen 69of the tube 55 of the module 50, and connecting the module 50 to thebody 31 of the handle for viewing portions of a vessel, cavity, ortissue when a distal end of the tube 55 is positioned therein.

The catheter 20 and methods of the present invention further provide adetachable catheter with a reusable fiber optic scope 90 which can bedetachably connected to the handle 30 and sealed within the detachablemodule 50 during a medical procedure. A steerable catheter 20 having adisposable module 50 and a sterilizable handle 30 according to thepresent invention also can advantageously be provided in a kit 200which, for example, includes a plurality of detachable, disposablemodules 50 and a reusable handle 30 and also may include a fiber opticscope 90 to be used with the disposable modules. The kit 200, forexample, provides the practitioner with an apparatus and method whichallow a first module 50 to be connected to the handle 30 for use in acavity, vessel, or tissue during a medical procedure such as agynecological, epidural, neurological, nose, brain, cardiovascular,thoracic, or other procedure as understood by those skilled in the art.The first module 50 can then be disconnected and disposed of by placingit into a sanitary container or other means of properly disposing of aused and/or contaminated device. The handle 30 can then be sterilizedand a second module, e.g., sterile module from the kit 200, connected tothe body 31 of the handle 30.

The handle 30 of a steerable catheter 20 according to the presentinvention can further include the angled handle that provides entry,e.g., preferably along a substantially straight axis, into a portion ofthe human body while allowing the medical practitioner to grasp thesteerable catheter in an advantageous hand position. A detachablesteerable catheter 20 can also advantageously include the camera 156mounted internally in the handle of the catheter wherein the handle canbe sterilized with the camera therein and the camera is protected frombreakage or contamination therein. A steerable catheter and methodsaccording to the present invention further can provide a steerablecatheter having a focus means positioned on the handle of the catheterfor focusing the internal camera positioned within the handle. Asteerable catheter 20 and methods of the present invention alsoadvantageously provide a disposable module and a sterilizable handlehaving a focus wheel and control wheel disposed such that the focuswheel and control wheel can be simultaneously adjusted by the same handof the practitioner.

In the drawings and specification, there have been disclosed preferredembodiments of the invention, and, although specific terms are employed,these terms are used in a descriptive sense only and not for purposes oflimitation. The invention has been described in considerable detail withspecific reference to various illustrated embodiments. It will beapparent, however, that various modifications and changes can be madewithin the spirit and scope of the invention as described in theforegoing specification and defined in the appended claims.

We claim:
 1. A steerable catheter kit comprising:a package; a pluralityof disposable modules positioned in the package, each said disposablemodule including an elongate tube having at least one lumen extendingfrom a distal end to a proximal end of said tube, a module interfaceconnected to the proximal end of said tube, and deflecting meansconnected to said tube for deflecting the distal portion of saidelongate tube; and a reusable handle positioned in the package for beingdetachably connected to said module and being configured to be readilyheld in the hand of a user, said handle comprising a body including awall positioned in distal portions of said body, said wall having anouter surface thereof defining an exterior portion of said body, and afirst cavity formed within said body, said body being detachably andcoextensively connectable to said module interface through the outersurface of said wall, and control means connected to said body anddetachably connectable to said deflecting means of said module forresponsively controlling said deflecting means to thereby manipulatedistal portions of said elongate tube, said control means and saiddeflecting means being connectable to define a unitary cathetermanipulation means extending from said first cavity, through said wall,and to said tube for manipulating a distal portion of the catheter whenpositioned within a vessel, cavity, or tissue.